Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001204730
Ethics application status
Approved
Date submitted
2/09/2022
Date registered
8/09/2022
Date last updated
2/12/2022
Date data sharing statement initially provided
8/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of nutraceutical therapies on symptoms in adults with long-COVID-19: The Alliance Long COVID-19 Treatment Trial
Scientific title
Development of a 2-stage nutraceutical treatment protocol for adults with long-COVID-19 syndrome, exploring underlying pathophysiology and treatment effectiveness
Secondary ID [1] 307906 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID-19 Syndrome 327543 0
Condition category
Condition code
Infection 324642 324642 0 0
Other infectious diseases
Inflammatory and Immune System 324643 324643 0 0
Other inflammatory or immune system disorders
Respiratory 324644 324644 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2-staged intervention after baseline and 6 week assessments:
Stage 1 (1-6th week): 6 week nutritional supplement consisting of 35g pineapple powder + 2x3g ginger infused oil per day to be consumed at meal-times with food as convenient; adherence monitored by diary
Stage 2 (7-12th week): 3 groups: Allocation by location and referral by the trial doctor.
Group 1 will receive 30g of Intravenous Vitamin C twice weekly for 6 weeks, administered by a registered nurse,
Group 2 will receive all of the following oral supplements as capsules [Kyolic aged garlic extract (1.2 g) + Fish oil (2g) + Curcumin (500mg) + N-acetylcysteine (600mg) + Vitamin D (5000 IU) + Vitamin C (1g) + Zinc (15mg)] daily for 6 weeks, administered by the principal investigator; adherence will be monitored by return of unused supplements at the end of the 6 week period
Group 3 will continue to receive the nutritional supplement consisting of 35g pineapple powder + 2x3g ginger infused oil per day to be consumed with food at meal-times as convenient for 6 weeks; adherence monitored by diary
Intervention code [1] 324366 0
Treatment: Other
Comparator / control treatment
The patients are their own control. Treatment effectiveness will be assessed by comparison of symptoms before and after the intervention(s), Symptom assessment will be done at baseline, 6 weeks (after intervention 1) and 12 weeks (after intervention 2).
Control group
Active

Outcomes
Primary outcome [1] 332453 0
Symptom score
assessed by online symptom questionnaire developed for this trial
Timepoint [1] 332453 0
6 weeks after completion of intervention 1 and at 12 weeks after completion of intervention 2 compared to baseline
Secondary outcome [1] 413585 0
Composite Blood test results including Full blood cell count, D-Dimer, High-sensitivity C-reactive protein (hsCRP), erythrocyte sedimentation rate (ESR), histamine, thyroid function, Kidney/Liver Function,Vitamin D levels
Timepoint [1] 413585 0
12 weeks after completion of both interventions 1 + 2 compared to baseline
Secondary outcome [2] 413586 0
Composite testing: Viral reactivation of EBV (Epstein-Barr-Virus), CMV (Cytomegalovirus) and/or HSV (Herpes simplex virus)
assessed by inhouse developed Pathogen Blood Test - consiting of cytological analysis of isolated human cells followed by viral antibody Immuno-Cyto-Chemistry
Timepoint [2] 413586 0
12 weeks after completion of both interventions 1 and 2 compared to baseline,

Eligibility
Key inclusion criteria
Had COVID-19, evident by PCR or RAT, more than 3 months ago
Persistent symptoms longer than 3 months
Referred to and assessed by trial doctor as suitable for the trial
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not able to provide consent
Major illness requiring medical intervention and/or hospitalisation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
2-staged treatment:
Intervention Stage-1: Single group design - all participants will undergo same intervention, Intervention Stage 2: Parallel group design - participants will be allocated to one of 3 treatment groups; allocation by location and referral by trial doctor
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive for baseline measure.
Pre-post comparison of each participant and between and within group analysis of 12 week data compared to baseline by t-test, or chi-square.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/10/2022
Actual
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
60
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment postcode(s) [1] 38456 0
3122 - Hawthorn
Recruitment postcode(s) [2] 38457 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 312178 0
Charities/Societies/Foundations
Name [1] 312178 0
Rinehart Medical Foundation
Country [1] 312178 0
Australia
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 313703 0
None
Name [1] 313703 0
Address [1] 313703 0
Country [1] 313703 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311563 0
National Institute of Integrative Medicine Human Research Ethics Committee (NIIM HREC)
Ethics committee address [1] 311563 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Ethics committee country [1] 311563 0
Australia
Date submitted for ethics approval [1] 311563 0
02/08/2022
Approval date [1] 311563 0
24/10/2022
Ethics approval number [1] 311563 0

Summary
Brief summary
A large number of people experience long-COVID Symptoms persisting for weeks and months after overcoming the acute illness. Symptoms include chronic fatigue, breathlessness, muscle pain, persistent cough, loss of sense of smell and/or taste. This study aims to explore underlying disease etiology by a series of blood tests and clinical assessment, followed by a staged treatment approach of 2x 6 weeks. After clinical assessment by a trial doctor, eligible participants will receive intervention-1 for a 6-week period, and allocated to one of three groups of intervention in the 2nd 6-week period. This study is exploratory, and will provide important insights for protocol development for a larger cohort study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121554 0
A/Prof Karin Ried
Address 121554 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 121554 0
Australia
Phone 121554 0
+61 3 9912 9545
Fax 121554 0
Email 121554 0
karinried@niim.com.au
Contact person for public queries
Name 121555 0
A/Prof Karin Ried
Address 121555 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 121555 0
Australia
Phone 121555 0
+61 3 9912 9545
Fax 121555 0
Email 121555 0
karinried@niim.com.au
Contact person for scientific queries
Name 121556 0
A/Prof Karin Ried
Address 121556 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 121556 0
Australia
Phone 121556 0
+61 3 9912 9545
Fax 121556 0
Email 121556 0
karinried@niim.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.